FDA.reportPublic FDA data

Alocane Max

Manufacturer
Quest Products LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:17

Label at a glance#

ProductAlocane Max
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

First aid to help prevent bacterial contamination or skin infection, and for temporary relief or pain and itching associated with minor: Burns Cuts Sunburn Scrapes Minor Skin Irritations

Dosage and administration

Adults and children 2 years of age and older: Clean affected area and let dry. Gently apply the Burn Pad over the burn or wound. Cover with adhesive tape or stretch gauze. Use on affected area not more than 3 or 4 times daily. Children under 2 years of age: ask a doctor.

Storage and handling

Store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose

Benzalkonium Chloride 0.13%

Lidocaine HCL 4%

First Aid Antiseptic

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

First aid to help prevent bacterial contamination or skin infection, and for temporary relief or pain and itching associated with minor:

  • Burns
  • Cuts
  • Sunburn
  • Scrapes
  • Minor Skin Irritations

Warnings

WARNINGS SECTION

For External Use Only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • Deep or puncture wounds
  • Animal Bites
  • Serious burns

OTC - DO NOT USE SECTION

Do not use:

  • In or near the eyes
  • In large quantities or over large areas of the body
  • On raw surfaces or blistered areas

OTC - STOP USE SECTION

Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Clean affected area and let dry. Gently apply the Burn Pad over the burn or wound. Cover with adhesive tape or stretch gauze. Use on affected area not more than 3 or 4 times daily.

Children under 2 years of age: ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.

PRINCIPAL DISPLAY PANEL - 10 Pad Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10pcPDP10pcPDP

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-407-01Alocane Max3 mL in 1 POUCHLIQUID32
68229-407-02Alocane Max10 in 1 CARTONLIQUID102
68229-407-03Alocane Max12 in 1 CARTONLIQUID122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-407ALOCANE MAX (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) LIQUID [QUEST PRODUCTS LLC]2Current NDC, 3 package rows20241107_0a35ac19-6883-a733-e063-6294a90ad22d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-407-02EA - Each68229-4071ec75cd3-28d3-4104-8466-04e96203ac7312023-12-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-40768229-407-01, 68229-407-02, 68229-407-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
ndc (package): 68229-407-02
ndc (package): 68229-407-03
ndc (package): 68229-407-01
ndc (product): 68229-407
ndc11 (package): 68229040702
ndc11 (package): 68229040703
ndc11 (package): 68229040701
spl id: 262e192e-cfcc-6344-e063-6294a90af4c5
spl set id: 0a35ac19-6883-a733-e063-6294a90ad22d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.